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New treatment option for Solid Tumors
Official title First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06644755
What this study is testing
What is DS-2243a?
DS-2243a is an investigational medicine, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sign and date the main ICF.
- Adults ≥18 years at the time the biosample ICF or main ICF, whichever is signed first. Follow local regulatory requirements if the legal age of...
- One of the following histologically or cytologically documented cancers: Advanced (metastatic or unresectable) SS Advanced (metastatic or...
- Relapsed from, refractory to, or intolerant to appropriate therapies [eg, standard of care (SOC) therapy] to provide clinical benefit for their...
- HLA-A\ 02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11 positive.
You likely can't join if
- Has received prior therapy targeting NY-ESO-1.
- Has an inadequate treatment washout period prior to the start of trial intervention, defined as follows:
- Radiation therapy: \<4 weeks (or \<2 weeks if palliative radiation therapy without abdominal/pelvic radiation)
- Chemotherapy, antibody-based anticancer therapy, immunotherapy: \<4 weeks
- Small molecules (eg, tyrosine kinase inhibitors): \<2 weeks or 5 half-lives, whichever is longer
- Has known symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated...
See the full eligibility criteria
Who can join
- Sign and date the main ICF.
- Adults ≥18 years at the time the biosample ICF or main ICF, whichever is signed first. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
- One of the following histologically or cytologically documented cancers: Advanced (metastatic or unresectable) SS Advanced (metastatic or unresectable) MRCLS Metastatic or unresectable locally advanced NSCLC (Ad/Sq)...
- Relapsed from, refractory to, or intolerant to appropriate therapies [eg, standard of care (SOC) therapy] to provide clinical benefit for their condition as assessed by their physician and/or investigator. [For South...
- HLA-A\ 02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11 positive.
- Has measurable disease based on RECIST v1.1 on computed tomography/magnetic resonance imaging (CT/MRI).
- Is willing and able to provide adequate pre-treatment or archival tumor tissue sample.
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 at Screening.
- Meets the following required baseline local laboratory data within 14 days prior to start of trial intervention administration:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN) in participants with no liver metastasis, or ≤5 × ULN in participants with liver metastasis
- Total bilirubin (TBL) ≤1.5 × ULN (≤3 × ULN for participants with a documented history of Gilbert's syndrome)
- Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L
- Platelet count ≥100 × 10\^9/L
- Hemoglobin ≥8 g/dL
- Creatinine clearance (CrCl) ≥45 mL/min as calculated using the Cockcroft-Gault equation (Section 10.3.1) Note: Any blood or blood product transfusion is allowed up to 7 days before the hematology evaluations and any...
- a) A female participant of childbearing potential (CBP), as defined in Section 10.3.5.1, is eligible to participate if the following conditions are met: Participant is not pregnant as confirmed by highly sensitive...
- Avoid donating sperm. Note: Preservation of sperm should be considered prior to enrollment/randomization in this trial.
- Adhere to either of the following contraception methods:
- True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR
- Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential (see Section 10.3.5) PLUS partner use of an additional contraceptive method (see Section 10.3.5.2), as...
What rules you out
- Has received prior therapy targeting NY-ESO-1.
- Has an inadequate treatment washout period prior to the start of trial intervention, defined as follows:
- Radiation therapy: \<4 weeks (or \<2 weeks if palliative radiation therapy without abdominal/pelvic radiation)
- Chemotherapy, antibody-based anticancer therapy, immunotherapy: \<4 weeks
- Small molecules (eg, tyrosine kinase inhibitors): \<2 weeks or 5 half-lives, whichever is longer
- Has known symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of...
- Uncontrolled or clinically significant cardiovascular disease, including the following:
- Myocardial infarction within 6 months prior to screening
- Uncontrolled angina pectoris within 6 months prior to screening
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) ≤50% or lower than the institutional lower limit of normal
- QT interval corrected with Fridericia's formula (QTcF) interval \>480 ms
- Chronic steroid treatment (IV or oral) or any other immunosuppressive medication (ie, prednisone \>10 mg daily (QD) or the equivalent).
- Has active other primary malignancies. Note: Participants with the following can be enrolled: Adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial cancer in the gastrointestinal...
- Has unresolved toxicities from previous anticancer treatment, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0...
- Chemotherapy-induced peripheral neuropathy
- Residual toxicities from prior immuno-oncology treatment: Grade 2 endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycemia due to type 1 diabetes mellitus) with adequate therapy Grade 2...
- Has known hypersensitivity to biological agents.
- Has a history of or active autoimmune disease. Note: Participants with the following examples may be enrolled as an exception:
- Type I diabetes mellitus/hypothyroidism only requires hormone replacement.
- Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
- Has human immunodeficiency virus (HIV) infection. Participants must be tested for HIV viral load during the Screening Period if acceptable by local regulations or Institutional Review Boards/Independent Ethics...
- Have CD4+ T-cell count ≥350 cells/mm3 at the time of screening.
- Have virologic suppression, defined as confirmed HIV RNA level below 50 or the lower limit of quantitation (below the limit of detection) at the time of screening and for at least 12 weeks before screening.
- Have no acquired immunodeficiency syndrome-defining opportunistic infections or conditions within the past 12 months.
- Are on stable antiretroviral therapy regimen, without changes in drugs or dose modification, for at least 4 weeks before trial entry (Day 1) and agree to continue antiretroviral therapy throughout the trial, as defined...
- Has active or uncontrolled hepatitis B or C infection as defined per institutional guidelines. Note: For Part 2 only, the following participants will be eligible:
- Hepatitis B surface antigen (HBsAg)-positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to allocation...
- Have a history of hepatitis C infection and hepatitis C virus (HCV) viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks.
- Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \<3 × ULN, which are not attributable to HCV infection.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Leuven, Belgium
- Lyon, France
- Amsterdam, Netherlands
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Nashville, Tennessee, United States; Leuven, Belgium; Lyon, France; Amsterdam, Netherlands and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.